1. Technical Field
The present disclosure relates to cartons designed for use in blinded clinical trials, and, more specifically, to sealable, single use zipper cartons adapted for assembling blinded clinical test kits, and to related methods of assembly and use.
2. Relevant Technology
Clinical trials for many pharmaceutical drugs require that a drug and a placebo be delivered and administered in a blinded study. As part of the blinded clinical trial protocols, the drug and placebo are placed in separate unmarked containers. Accordingly, the administering technician and recipient are blind as to the identity of the product, the concentration thereof, or other characteristic being studied that may otherwise be reported on the retail label of the drug container.
To facilitate transport and delivery of the drug/placebo, the unmarked containers can be sealed in a box. For instance, an unmarked dosage vial or tube can be placed in a box having a lid that can be folded over to close the box. Once the lid is closed, a sealing sticker is manually placed on the outside of the box so as to extend between the lid and the body of the box, thereby fixing the lid closed and sealing the contents therein. The unbroken sealing sticker indicates that the box has not been opened following sealing of the product therein. The box can also be marked with a label that includes an identification number or other information associated with the included product. However, this identifying information is keyed to a reference list and is only useful in identifying the product in combination with that list. Accordingly, the box may also lack any direct, product-identifying marks or labels to ensure fidelity of the blinded study.
One of the difficulties in conducting blinded trials is ensuring that there is no indirect identifying and/or associating information that can inadvertently convey to the participants information about the drug/placebo they are taking. For instance, variation between the placement (e.g., location, orientation, etc.) of the sealing stickers on the boxes can provide an indication of product identity. Specifically, differences in the placement of sealing stickers between adjacent boxes or between current and former boxes may cause a participant to infer that the products between the two boxes are different or that one box is more likely to have an active drug as opposed to a placebo. Such perceived differences can defeat the objective of the blinded trials. Because even slight differences between the human-applied sealing stickers on two separate boxes can lead the technician or recipient to believe that the containers disposed therein contain different products, controlling such perceived differences can be vital to the efficacy and fidelity of the clinical trial.
Accordingly, what is needed in the art are blinded trial boxes and assemblies that overcome all or some of the above shortcomings.